Global Technical Science Head

Legend Biotech is seeking Global Technical Science Head as part of the Global MSAT team based Remote. 

Role Overview

This position is a lead technical role in the global MSAT organization. This individual will be responsible for all technical and scientific scope for the approved Carvykti commercial process and overall program within Legend and with our program partner Janssen. This effort will extend to representing MSAT on joint technical and CMC committees. The candidate will also be required to drive the technical program for a best-in-class high volume marketed CAR-T product to achieve significant reduction in out of specification, turnaround time and cost of goods. This effort is business critical and part of a multi-site global manufacturing network whose aim is to maintain Legend’s competitive advantage in the Multiple Myeloma space. This individual is required to ensure the success and overall sustainability of global commercial program by adhering to industry best practices and sound cell therapy technical principles and deliver a process platform is robust and consistent. Portfolio management and partner collaboration is required to implement process improvements, optimization, capacity expansion, and cost of goods / non-conformance reduction efforts worldwide.

Key Responsibilities  

• Represent MSAT at joint technical and CMC committees
  
• Partner closely with senior Janssen technical team to achieve global alignment on all technical Carvykti scope
  
• Provide technical leadership for an expanding global manufacturing network for best-in-class CAR-T product
  
• Develop complex analyses from manufacturing data to enable data driven decision making and plans
  
• Develop business plans and key financial analysis in support of major process changes
  
• Work collaboratively with internal and external partners to drive major global process platform improvements and cost reduction initiatives
  
• Responsible for executive oversight over Technology Lifecyle including, but not limited to; strategic partnerships, proof of concept, requirements, design, build, testing, site implementation, validation and successful cGMP manufacturing
  
• Provides direction into laboratory studies in support of process improvement projects globally
  
• Provides strategic input and direction on appropriate automation/capital project/tech transfers globally
  
• Seeks out and maintains key collaborations with process equipment vendors or technology providers develop improved commercial processes
  
• Supports technology roadmap as part of a cross functional team
  
• Drive strategy across multiple disciplines and functions to implement significant process changes / improvements, increase robustness, drive down OOS rates and improve delivery times to patients

Requirements

• B.S. required, Ph.D. preferred in technical discipline: engineering, science, or related field
• Minimum 12 years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly desirable.
  
• Extensive experience in cell therapy commercial cGMP program with end-to-end know-how to manage process platform changes/improvements in a global manufacturing network and change management process.
  
• Candidate must have extensive experience in Cell Therapy tech transfer and/or MSAT.
• Extensive experience in a cross functional CMC team as a technical representative driving global commercial programs in cell therapy
  
• Extensive Experience as a technical leader in driving significant commercial process improvements and changes in order to reduce out of specification, turnaround time and cost of goods
  
• Experience in driving consistency across multiple manufacturing sites.
  
• Experience in collaborating with external partners and CMOs preferred
  
• Industry leading knowledge in process development, technology transfer, process comparability, CMC regulatory guidelines and enabling technologies in cell therapy.
  
• Ability to think critically and demonstrated troubleshooting and problem-solving skills.
  
• Results driven with strong analytical, problem solving and critical thinking skills.
  
• Strong experience working in a cross-functional organization with multiple partners with competing priorities.
  
• Ability to plan, multitask, prioritize and be an effective and influential decision maker focused on action and implementation.
• Language: English

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